A contract research organization (“CRO”) is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced by one or more sponsor companies on a contract basis. Research services may include, for example, biopharmaceutical development, biologic assay development, commercialization, pre-clinical research, clinical research, clinical trials management, and pharma-covigilance, among others. Contract research organizations may also provide clinical-study and clinical-trial support for drugs and/or medical devices.
To conform to regulatory guidelines and policies on the handling of clinical data and to secure intellectual property (“IP”) assets, sponsor companies typically mandate that the contract research organizations input their experimental data into the sponsor companies' central Electronic Laboratory Notebook (“ELN”) system. An electronic laboratory notebook is generally a computing application that replaces paper laboratory notebooks used by scientists, engineers, and technicians to document research, experiments, and procedures performed in a laboratory. Entries into laboratory notebooks are often governed by guidelines and policies of a given organization and/or company.
Existing products for managing contract research organization's data often fail to account for the specific requirements of this service and, thus, do not adequately meet the need for security, privacy, performance, and consistency. For example, some existing products allow a contract-research-organization remote access to a sponsor companies' central electronic laboratory notebook database to input/update their data. This access is not only unnecessary to synchronize data between the various databases; it poses risk to security, theft, privacy, and industrial espionage. Additionally, because a given sponsor company's electronic laboratory notebook may have many users and notebook collections, having additional members from the contract research organization share the same resource may degrade the performance of such systems. Moreover, network latency and performance issues associated with live-update of the research data via remote operation may further generate unnecessary delays and inconvenience for the contract-research-organization members.
FIG. 1 is a prior art system for managing data between a contract-research-organization data and a sponsor company's electronic laboratory notebook. To upload or update a sponsor company's electronic laboratory notebook, a set of contract-research-organization researchers remotely login to an electronic laboratory notebook operating at the sponsor company and update the data via an E-Notebook client. The remote login may be made by way of a virtual private network (“VPN”) using a virtualization server (for example, a Citrix server). The contract-research-organization researcher may update the electronic-laboratory-notebook entries manually and remotely. Analysts working for the sponsor company may then analyzed the research data. When accessed by a large number of users, such systems may provide slow performance to both the local and remote users.
Other existing systems allow a contract research organization to use an electronic-laboratory-notebook scheme of that of the sponsor company to create a project report in portable document format (“PDF”) at the end of the project. This type of products may create inconsistent work-flow between the contract research organization and the sponsor company. Moreover, different formats after the import creates further inefficiencies in the data transfer and when searching for specific information within the data.
Other existing systems allow a contract research organization to connect to a hosted electronic-laboratory-notebook server and database, where the data is separated from the sponsor company's main electronic-laboratory-notebook database. The product may employ a merge function, such as “extract-transform-load” to incorporate the contract research organization data into the sponsor company's database. This type of products may result in a potentially inconsistent work flow between the contract research organization and different sponsors. Additionally, the electronic-laboratory-notebook data formats may be different among the databases resulting in an integration issues.
There exists a need for an approach to an electronic-laboratory-notebook system that provides high performance and secure global remote access for users with requisite privacy protection and consistency.